CN103180219A - Packaging system for multi-component medical products - Google Patents
Packaging system for multi-component medical products Download PDFInfo
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- CN103180219A CN103180219A CN2011800518477A CN201180051847A CN103180219A CN 103180219 A CN103180219 A CN 103180219A CN 2011800518477 A CN2011800518477 A CN 2011800518477A CN 201180051847 A CN201180051847 A CN 201180051847A CN 103180219 A CN103180219 A CN 103180219A
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- package system
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- plate rail
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B5/00—Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
- B65B5/06—Packaging groups of articles, the groups being treated as single articles
- B65B5/068—Packaging groups of articles, the groups being treated as single articles in trays
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B5/00—Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
- B65B5/06—Packaging groups of articles, the groups being treated as single articles
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
- B65D25/02—Internal fittings
- B65D25/10—Devices to locate articles in containers
- B65D25/108—Devices, e.g. plates, presenting apertures through which the articles project
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D71/00—Bundles of articles held together by packaging elements for convenience of storage or transport, e.g. portable segregating carrier for plural receptacles such as beer cans or pop bottles; Bales of material
- B65D71/70—Trays provided with projections or recesses in order to assemble multiple articles, e.g. intermediate elements for stacking
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/52—Details
- B65D75/527—Tear-lines for separating a package into individual packages
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B2220/00—Specific aspects of the packaging operation
- B65B2220/14—Adding more than one type of material or article to the same package
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B2220/00—Specific aspects of the packaging operation
- B65B2220/16—Packaging contents into primary and secondary packaging
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B29/00—Packaging of materials presenting special problems
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Dispersion Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Basic Packing Technique (AREA)
Abstract
A sterile packaging system for use in the manufacture and sale of combination medical product preferably one that is attachable to an injection system to co-deliver at least two medicaments is disclosed where a tray grid (1) comprises sterile receptacles (2) that are removably connected, sealable and configured for use in an automated drug filling and assembly line.
Description
Technical field
Specific embodiment of the present disclosure relates to: a kind of encapsulation or plate rail system, use in the produce and market of its and/or medical product that consist of (combination of medicament and medical treatment device) that assemble at a plurality of parts, described medical product is for example the medicine carrying module for medical delivery apparatus; Particularly, this class device is used for: utilize the device only have single dose set mechanism and single dispensing interface, send at least two kinds of pharmaceutical preparations from receiver independently, wherein, a kind of medicine is contained in described encapsulation.By the initialized single delivery program of the user of delivery apparatus, second pharmaceutical preparation of (non-user settable) dosage that non-user can be able to be set and the first pharmaceutical preparation of variable setting dosage are delivered to the patient.This second pharmaceutical preparation can be contained in the medicine carrying module, and described medicine carrying module is contained in package system of the present disclosure.The disclosure has specific benefit, because can keep described medicine carrying module in the sealing of filling with the aseptic in the process of pharmaceutical preparation and described medicine carrying module in whole Fabrication procedure process.In addition, the disclosure minimizes by the amount of the sterile packaged material that final drug products is required and the quantity of process, thereby bootable to cost actv. Fabrication procedure.
Background technology
Specific morbid state requires treatment to adopt one or more different medicaments.In order to send best dosage, some medical compounds need to be sent with specific relation to each other.The disclosure is in the situation that the expectation combination treatment has specific benefit, but is impossible in single formula, and reason is such as but not limited to compromise curative effect performance and toxicity, stability.
For example, in some cases, the glucagon-like-peptide-1 of translating product (glucagon-like peptide-1, GLP-1) the treatment diabetes of utilizing protamine zine insulin and utilization to come from glicentin protogene (proglucagon gene) may be useful.GLP-1 is found in vivo and is hidden as gastrointestinal hormone by intestines L cell.GLP-1 has multiple physiology characteristic, makes its (with its analogue) become the theme of in-depth study as a kind of possible therapeutant of diabetes (diabetes mellitus).
When sending two kinds of active agents or " preparation " simultaneously, there is multiple potential problem.Mutual effect each other during described two kinds of active ingredients may store at the long-term shelf of this formula.Therefore, maybe advantageously, activating component is deposited separately and only the moment combination of sending for example injection, needle-free injection, pumping into or sucking they.Yet, be used for the processing of two preparations of combination, need to be simply and easily to the user, in order to carry out reliably, repeatedly and safely.
Another problem is, consists of amount and/or the ratio of each activator of combination treatment, may need to be changed to every user or in their different phase of the course for the treatment of.For example, one or more activators may require the titration phase the patient is directed to gradually " keeping " dosage.Another example will be, if an activator requires non-adjustable fixed dosage, and another activator is changed in response to patient's symptom or condition.This problem means that the preparaton that is pre-mixed of multinomial activator may be unaccommodated, because these preparatons that are pre-mixed may have the fixed ratio of activating component, and described ratio can't be changed by health professional or user.
Other problem appears in the situation that requires multinomial medical compounds therapy, because many users can not deal with following situation, namely has to use and makes up the situation of carrying out necessary accurate Calculation more than a drug delivery system or to required dosage.This is for especially true for inconvenient user aspect automaticity or calculating.In some cases, also be necessary (priming) program of reinstating of before dispensing medicament executive device and/or needle cannula.Similarly, in some cases, may be necessary to walk around a medical compounds and only dispensing from the individual event medicament of independent memory.
Therefore, strongly need to provide a kind of apparatus and method, described apparatus and method are used for user single injection or delivery step simple to operate are being sent two or more medicaments.Above-mentioned problem can be overcome by following means, described means are two or more pharmacological activation preparations independent storing containers are provided, and then described two or more pharmacological activation preparations only are combined in the process of single delivery program and/or are delivered to the patient.Especially, the medicine carrying module of holding the single dose medicament must make separately to use together with main ingredient thing delivery apparatus.The disclosure provides a kind of encapsulation, container or plate rail system, its preservation hold the part of time medicament assembling with medicine carrying module finished product from the beginning of making until the aseptic the whole process when being attached to by the user delivery apparatus that holds major pharmaceutical.
These and other advantage will become obvious from following more detailed description of the present invention.
The problem that solves
The problem to be solved in the present invention is to provide a kind of package system and method, and wherein user's safety is increased.
Summary of the invention
The disclosure comprises a kind of package system, its allow medical product that a plurality of parts are assembled or device efficiently and the manufacturing of cost actv..A this multi-part formula (multi-component) medical treatment device can comprise the medicine carrying module.The medicine carrying module can be designed to for example use together with injection device with the drug delivery system that holds the first medicament.The medicine carrying module can be held the second medicament, and when being attached to main ingredient thing delivery system, and its tolerable user sends the multiple medicines compounds of the complex combination in single drug delivery system by once enabling step.Described package system can be configured to enter as the aseptic plate rail grid (tray grid) of container to be made and/or assembling procedure, described container holds at least one sub-component that finished product product to be assembled into is used for the specific medical product of sale, and described medical product is the medicine carrying module for example.In the assembling procedure process, additional parts can add described at least one sub-component to, until the multi-part formula medical product of final complete, for example medicine carrying module.In the assembling procedure process, medicine or other material can add described at least one sub-component to, or add other parts that comprise described medical product to.When leaving manufacturing/assembling procedure, the sealed type aseptic packaging of holding the predetermined quantity container is arranged, each container keeps: pre-available distribution and used by healthcare provider or patient, finished product for the multi-part formula medical product for preparing.
The disclosure can be minimized with the waste of Fabrication procedure, because the outer jointing jacket cylinder that enters (incoming) plate rail and the lid sealing member of described plate rail self only need be set.Described plate rail can be carried in whole Fabrication procedure.Hold the part of the described plate rail of finished product medicine carrying module and can finally pass through commercial packages to be distributed to the end user.Especially, the aseptic plate rail grid of container can be configured to be partitioned into end user's grid used.Further, described aseptic plate rail grid can be configured to be placed in commercial packages.So, total Fabrication procedure can be designed to more efficient and not too complicated.The package system of described plate rail can be with certain material structure and making, so described material can bear the manufacturing of high speed/high-throughput and can realize the efficient filling of a plurality of sub-components of module in the single program because of each the container holding module sub-component in the grid of described plate rail system.Each sub-component in described plate rail system can be accurately positioned, fill to be used for automation by the member of putting that utilization is arranged in each container.Described single disc frame system tolerable: carry out the plant-scale manufacturing of cost actv. by the manufacturing principle that the automation system utilization is set up.According to plate rail system of the present disclosure thereby can be used in the manufacturing process of multi-part formula medical product and in the process for end user and/or commercial packages.Described plate rail system can comprise: be configured for for manufacturing steps such as assembling and filling and unit or sub-component are remained on feature in the exact location, for example, and can further comprise the feature of the final encapsulation that can be suitable for individual cell.
Relate in one aspect to package system.Described package system can use in the manufacturing process of multi-part formula medical product, and described medical product is the medicine carrying module for example.Further, described package system can be suitable for the multi-part formula medical product that keeps complete.Described package system can comprise aseptic plate rail grid.Described plate rail grid can be square.Described plate rail grid can comprise at least two containers.Preferably, described plate rail grid comprises a plurality of containers.Described container is attachable, preferred connection releasedly.Each container can have the top seal surface.Each container can have inner cavity chamber.Described inner cavity chamber can have puts middle member.Describedly put the sub-component that middle member can be configured to support multi-part formula medical product.Describedly put two or more sub-components that middle member can be configured to support multi-part formula medical product.Described two or more sub-components can form corresponding multi-part formula medical product, for example medicine carrying module.
Each container can be connected to adjacent container removedly.Especially, each container can be connected to via level bearing and preferably be connected to removedly adjacent container.Described level bearing can be eyelet (perforation).
Described grid comprises: preferably be releasably connected to vessel array each other via level bearing.This level bearing allows that the user is by submitting to and once break off with the fingers and thumb disconnected or fracture or differently cut off in addition one or more containers or pull apart one or more containers from described array to palintrope from described array.In some cases, described level bearing can be the actual eyelet that marks the profile of one or more containers.Each container also preferably has folded edge, and described folded edge tolerable user removes the hermetically-sealed construction that hides described inner cavity chamber.Described sealing member remove taking and removing of the described finished product medicine carrying of tolerable module.Described plate rail also can be designed to the final encapsulation as filled type medicine carrying pin.
According to embodiment, described aseptic plate rail grid comprises 2 to 400 containers.Described aseptic plate rail grid can comprise 7 to 210 containers.Preferably, described aseptic plate rail grid comprises 7 to 28 containers.
Preferably, the selection of initial lattice dimensions (quantity of the container that namely connects) is by determining for the investigation of the manufacturing equipment of filling, assembling and seal described medicine carrying module.Lattice dimensions can be in the scope of a unit, 2 * 1 unit to 10 * 40 or 2 to 400 containers.Most preferably, the lattice dimensions of 7 * 10 unit or 14 * 10 unit is best.Other the grid that has identical linkage unit quantity sets, and is also possible and in the scope of the present disclosure.
According to embodiment, a plurality of aseptic plate rail grids are stacking each other.
According to embodiment, each container has folded edge.Described folded edge can be configured to allow that the user removes the hermetically-sealed construction that hides described inner cavity chamber.Each container can have the sealed bottom surface.
According to embodiment, described inner cavity chamber is configured to receive the part of automatic chemical drug thing filling machine temporarily.
According to embodiment, each container is molded with plastics.Described plastics can be had enough rigidity, so as through the automation medicine fill and assigned line in processing.Additionally or alternatively, each container can be with can be molded with the plastics of gamma ray sterilization.Additionally or alternatively, each container can be with can be molded with the plastics of epoxyethane (ethylene-oxide) sterilization.
Described grid can make with the material that for example gamma ray, epoxyethane (ethylene-oxide), hydrogen peroxide (H202), electron ray or analogue carry out disinfection with any type.easily reclaim in order to make cost minimization and to allow, preferred described grid is molded by one or more plastic material, most preferably the plastics of selecting from the group that following substances consists of, described material is: polyolefin (polyolefines) (polypropylene (polypropylene), polyethylene (polyethylene), polyisobutene (polyisobutylene), polybutene (polybutylene) etc.), polystyrene (polystyrene), polyester (polyester), polyethylene terephthalate (polyethylene-terephthalate), polyamide (polyamides), and their compound or laminate.Described grid can use deep-drawing or injection moulding technology manufacturing.
According to embodiment, each container holds the sub-component for described multi-part formula medical product.Described sub-component can be put middle member support by described.Described sub-component can be fixed and avoid being relevant to described container motion, and particularly being fixed avoids rotatablely moving.Described sub-component can be fixed and avoid putting middle member and moving by means of described.Describedly put middle element and can be configured to: described medical product or its at least one sub-component are positioned at are in accurate position in described container and it is fixedly avoided motion.Keeping described sub-component to be in accurate position will be provided for utilizing described plate rail system to carry out automated manufacturing and number of assembling steps on the high speed manufacturing equipment.For example, the second sub-component can be connected to or be arranged on described the first sub-component, wherein, describedly puts middle element with described the first sub-component location and fixedly avoids moving.The element of described manufacturing equipment therefore can be fill and a plurality of manufacturing steps such as assembling and with the sub-component mutual effect that is contained in described container.Preferred high speed manufacturing equipment is processed 200 unit of 60 – with per minute.
According to embodiment, described top seal face joint is to the removable sealing member.Described grid can be wrapped in removable inferior sealing member.
According to embodiment, each container holds the multi-part formula medical product of finished product, for example the medicine carrying module of finished product.In this embodiment, the top seal surface of each container also can join the removable sealing member to.Described removable sealing member can have the eyelet that marks each container profile.
Relate on the other hand package system.Described package system can comprise: have 2 to 400, preferred 7 to 210, the aseptic plate rail grid of the container of most preferably 7 to 28 connections.Each container can have the top seal surface.Each container can have folded edge.Each container can have inner cavity chamber.Described inner cavity chamber can have puts middle member.Each container can have the medicine carrying module of finished product in described inner cavity chamber.The medicine carrying module of described finished product can be positioned on described putting on middle member.Each container can have sealing member.It is surperficial that described sealing member can join described top seal to.Each container can be connected to and preferably be connected to removedly adjacent container.Each container can be connected to via level bearing adjacent container.
According to embodiment, described medicine carrying module is held time medicament, the inferior medicament of preferred single dose.Described medicament can be liquid.Described medicine carrying module can comprise medicine dispensing interface, for example pin.This medicine carrying module can preferably be attached to drug delivery device releasedly.Described drug delivery device can hold major pharmaceutical, the major pharmaceutical of preferred multiple dose.
According to embodiment, described time medicament comprises GLP-1.Perhaps, described medicament can comprise the premix of insulin and GLP-1.
Described plate rail be segmentation or subregion, so that a plurality of containers of embarking on journey to be provided, and described parallel row matches with patient to be supplied to or user's a plurality of medicine carrying devices or setting subsequently of pin.In order to help to pull apart described paillon foil or the sealing member of the aseptic of keeping each finished product medicine carrying module, described folded edge is included on each container.This folded edge can be on the top or bottom of described container.Each container can be configured to will be fully the medicine carrying module with filling of assembling remain in described inner cavity chamber, described inner cavity chamber is preferably formed in the described manufacturing process that opens beginning grid (starting grid) and forms.Yet initially, the described container that opens the beginning grid can only keep the sub-component of described medicine carrying module, and described medicine carrying module is preferably without the second medicament.Described inner cavity chamber can with described put middle member be configured to described sub-component is kept or be positioned at predetermined vertical position, with the accurate filling of allowing described medicament be connected the connection of sub-component or sealing to form complete finished product medicine carrying module.Describedly put middle member and can comprise: sleeve pipe, support (shelf) or rib or may be to be configured to carry out with the part of described sub-component the molding part that form coordinates.The actual design that has nothing to do and put middle member in described, it should be allowed: in filling and the number of assembling steps process for the automated manufacturing line of completing described finished product medicine carrying module, described sub-component reservation spatially is fixed.Fixedly meaning on the space: the sub-component in described container is in fixing and preposition accurately, carries out mutual effect take the element of allowing the automation interstitial wire and described sub-component as filling and assembling procedure on the high-speed line of 100 unit of per minute processing.In arbitrary moment of described Fabrication procedure, location and the alignment of described sub-component in its container is fully known and definite.According to the shape of described sub-component and required process, described sub-component is fixed and avoids axial-rotation and apply moment by rotatablely moving for number of assembling steps in order to allow.In order to allow the machine filling work procedure, described sub-component need be fixed and vertically align with for example described filling needle, therefore will avoid the inclination of described sub-component.Further, described sub-component can be fixed in order to avoid horizontal motion is deviate from its holder, so as for assembling keep described desired location and with the mutual effect of mechanical characteristics.Described inner cavity chamber also answer tool have the dimensions, receiving the part of described automation medicine filling machine, described automation medicine filling machine can be carried out described sub-component and fill or assembly operation.Most preferably, described inner cavity chamber is configured to allow: with described sub-component mutual effect and keep simultaneously mechanization or the robot architecture be positioned in described inner cavity chamber.
Relate on the other hand a kind of method of using aseptic plate rail grid assembling multi-part formula medical product.Described method can comprise the step that package system is provided.Described package system can comprise: the aseptic plate rail grid of the container of at least two connections, for example open the beginning grid.Each container can have the top seal surface.Each plate rail can have inner cavity chamber.Described inner cavity chamber can have puts middle member.Each plate rail can have the first sub-component.Described the first sub-component can be positioned on described putting on middle member.Each container can be connected to adjacent container removedly.Described package system can all be contained in the first sealing member.In second step, described sealing member can remove in gnotobasis.In next step, at least the second sub-component can be connected to corresponding the first sub-component.In next step, the second sealing member can be attached to described sealing surfaces, with the aseptic plate rail grid of the corresponding finished product that forms sealed container.Each container can hold multi-part formula medical product.
In a step, medicament can add described the first sub-component under germ-free condition.The finished product plate rail grid of described sterile chamber can divide end user's grid used into and be placed in commercial packages.Described end user grid used can hold 2 to 28 containers.
The opening that the beginning grid is preferably sterilized and can have the first sealing member of the sealing surfaces that joins described plate rail to of described plate rail assembly of holding described sub-component.Perhaps, in some cases, need not sealing member or described plate rail and be enclosed in protection sleeve or bag.This sealed type plate rail system can the second air locking parcel or hides, and described the second air locking is bag, lid or similar once be positioned in the clean room, material that can easily remove when the beginning of automation filling and assembling procedure for example.Fill at described sub-component and be connected to initial sub-component with medicament and the second sub-component with after completing described medicine carrying module, it is surperficial that the 3rd sealing member is engaged to described seal of vessel.This 3rd seal configurations becomes to make each container to be independent and to seal removedly.Single sealing member material can join described grid to, then can bore a hole to form individual sealing member for each container around each container.In case used described the 3rd sealing member, described plate rail system can be divided or cuts into less lattice dimensions, facilitates the user's or predetermined dosage special package to adapt to.The lattice dimensions of 2 to 28 containers, the lattice dimensions of preferred 7 to 14 containers can be produced and individual packages.That each container can keep is aseptic, finished product, hold the module of single dose time medicament.Then these less lattice dimensions are encapsulated to be used for being distributed to the end user alone.
Although the disclosure may be used on the manufacturing of any multi-part formula medical product or device/assembling, this type of application is in the manufacturing of medicine carrying module, as described here, described medicine carrying module can be filled with many times medicament, for example any combination of insulin, insulin analog, insulin derivates, GLP-1 or GLP-1 analogue, analgestic (analgesics), hormone, beta-agonists (beta agonists) or corticosteroid (corticosteroids) or these compounds.
For purpose of the present disclosure, term " insulin " should refer to insulin, insulin analog, insulin derivates or their compound, comprises actrapid monotard or human insulin analogue or human insulin derivatives.The example of insulin analog includes but not limited to Gly (A21), Arg (B31), Arg (B32) actrapid monotard; Lys (B3), Glu (B29) actrapid monotard; Lys (B28), Pro (B29) actrapid monotard; Asp (B28) actrapid monotard; The actrapid monotard, wherein the proline in the B28 of position is by Asp, Lys, Leu, Val or Ala replaces and wherein in the B29 of position, Lys is replaced by Pro; Ala (B26) actrapid monotard; Des (B28-B30) actrapid monotard; Des (B27) actrapid monotard and Des (B30) actrapid monotard.The example of insulin derivates is (but being not limited to) B29-N-myristoyl-des (B30) actrapid monotard; B29-N-palmityl-des (B30) actrapid monotard; B29-N-myristoyl actrapid monotard; B29-N-palmityl actrapid monotard; B28-N-myristoyl Lispro; B28-N-palmityl-Lispro; B30-N-myristoyl ThrB29LysB30 actrapid monotard; B30-N-palmityl ThrB29LysB30 actrapid monotard; B29-N-(N-palmityl-Y-glutamy)-Des (B30) actrapid monotard; B29-N-(N-stone courage acyl-Y-glutamy)-Des (B30) actrapid monotard; B29-N-(ω-carboxyl heptadecanoyl)-Des (B30) actrapid monotard and B29-N-(ω-carboxyl heptadecanoyl) actrapid monotard.
As used herein, term " GLP-1 " should refer to GLP-1, GLP-1 analogue or their compound, include but not limited to: Exendin-4 (1-39), a kind of peptide with following sequence: H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Me t-Glu-Glu-Glu-Al a-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Se r-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2; Exendin-3; Liraglutide; Perhaps AVE0010 (H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Me t-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-As n-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pr o-Pro-Ser-Lys-Lys-Lys-Lys-Lys-Lys-NH2).
the example of beta-2-agonists includes but not limited to salbutamol (salbutamol), levosalbutamol (levosalbutamol), Terbutaline (terbutaline), pirbuterol (pirbuterol), Procaterol (procaterol), orciprenaline (metaproterenol), fenoterol (fenoterol), Bitolterol Mesylate (bitolterol mesylate), salmeterol (salmeterol), Formoterol (formoterol), bambuterol (bambuterol), clenbuterol (clenbuterol), QAB-149 (indacaterol).
steroids is for example hypophysis hormones or hypothalamic hormone class or regulates active peptide and their antagonist, such as being promoting sexual gland hormone (Gonadotropine) (follicle-stimulating hormone (FSH) (Follitropin), luteotropin (Lutropin), human chorionic gonadtropin (Choriongonadotropin), thylakentrin (Menotropin)), growth hormone (somatropine) (somatotropin (Somatropin)), minirin (Desmopressin), terlipressin (Terlipressin), Gonadorelin (Gonadorelin), Triptorelin (Triptorelin), Leuprorelin (Leuprorelin), Buserelin (Buserelin), nafarelin (Nafarelin), Goserelin (Goserelin).
In one embodiment, the sub-component of medicine carrying module preferably has the receiver that can be filled with time medicament.In most preferred structure, described receiver is filled with the medicament of single dose, preferred liquid medicament, for example premix of GLP-1 or insulin and GLP-1.Finished product medicine carrying module comprises the receiver with single dose medicament.Finished product medicine carrying module can comprise for the attached any structure of main ingredient thing delivery apparatus, described main ingredient thing delivery apparatus is for example injection device, is most preferably the pen type injection device that holds the multiple dose receiver of major pharmaceutical.Described medicine carrying module can comprise housing.Described housing can comprise: be configured to the adaptor union attached with drug delivery device.This housing comprises near-end and far-end.Described medicine carrying module can comprise the first needle cannula.Described the first needle cannula can be positioned in the near-end of housing of medicine carrying module.Described medicine carrying module can comprise the second needle cannula.Described the second needle cannula can be positioned in the far-end of described housing.Described the first and second needle cannula can be in fluid with the receiver of the medicament that keeps single dose and be communicated with.The medicine carrying module also can be held: needle shield or other safety gear that can hide the second needle cannula.Described medicine carrying module can be designed to and use together with any drug delivery device of the compatibility interface that is fit to.Yet, can be preferably, design in the following manner described module, thereby described mode is namely by adopting feature special-purpose or coding to prevent that non-applicable medicine carrying module is attached to non-matching device its use is restricted to a kind of exclusive main ingredient thing delivery apparatus (or device series).What in some cases, possibility was useful is to guarantee that this medicine carrying module is specific to a kind of drug delivery device and also allows simultaneously the medicine dispensing interface of standard to be attached to this device.This can allow that the user sends the therapy of combination when attached module, but also tolerable is sent main compound independently via the medicine dispensing interface of standard in some cases, described certain situation for example is not limited to, and the dosage of main compound is cut apart fill it up with (top-up) of (splitting) or main compound.
The main ingredient thing delivery apparatus that uses together with the medicine carrying module can use more than being once and therefore reusable version, yet, but drug delivery device can be also the disposal type device that single uses.The receiver that this device can or can not have removable main ingredient compounds.Also can have the different medicine carrying module of cover for various situations, can designatedly offer the patient of the drug delivery device of Application standard as disposable extra drug.If patient's attempt reuses the previous medicine carrying module of using, preferably include the needle shield that locking is used, thereby being activated at the medicine dispensing or after inserting, the needle shield that described locking is used remind the patient to note this situation.In case attached, medicine carrying module tolerable medicament is sent via an entry needle with in an injecting step.Than using twice independently injection, this is providing benefit easily to the user aspect minimizing user step.This easy benefit also can improved degree of conformity (compliance) with specifying therapy, particularly for disagreeable injection or inconvenient user aspect automaticity or calculating.The medicine carrying module can be filled with liquid, or alternatively is filled with powder, suspending fluid or slurry.In one embodiment, the medicine carrying module can be filled with the powder type medicament, and described powder type medicament is dissolved in major pharmaceutical or is entrained in major pharmaceutical when it is injected via the medicine carrying module.
According to preferred embodiment, a kind of package system is provided, comprise the aseptic plate rail grid of the container of at least two connections.Each container has top seal surface and inner cavity chamber, and described inner cavity chamber has the middle member of putting of at least one sub-component of being configured to support multi-part formula medical product.
According to preferred embodiment, a kind of package system that uses in the manufacturing process of multi-part formula medical product is provided, comprising: the aseptic plate rail grid of the container of at least 2 connections.Each container has top seal surface and inner cavity chamber, and described inner cavity chamber has the middle member of putting of a sub-component being configured to support multi-part formula medical product, and wherein each container is connected to adjacent container removedly.
According to preferred embodiment, a kind of package system is provided, comprise: 2 to 400, preferred 7 to 210, the aseptic plate rail grid of the container of most preferably 7 to 28 connections, wherein each container has: top seal surface, folded edge, have the inner cavity chamber of putting middle member, in described inner cavity chamber and be positioned at the described sealing member of putting the finished product medicine carrying module on middle member and joining described top seal surface to.Each container is connected to adjacent container removedly via level bearing.
According to preferred embodiment, a kind of method of using aseptic plate rail grid assembling multi-part formula medical product is provided, described method comprises the steps: to provide previously described package system, and described package system all is contained in sealing member.In further step, described sealing member removes in gnotobasis.In further step, at least one second sub-component is connected to described the first sub-component, to form the multi-part formula medical product of corresponding finished product.In further step, another sealing member is attached to described sealing surfaces, and with the aseptic plate rail grid of the finished product that forms sealed container, wherein, cell therefor holds corresponding multi-part formula medical product.
Provide a kind of method of using aseptic plate rail grid assembling multi-part formula medical product according to preferred embodiment, described method comprises the steps: to provide a kind of package system, this package system comprises the aseptic plate rail grid of the container of at least 2 connections, wherein, each plate rail has the top seal surface, has the inner cavity chamber of putting middle member and be positioned at described the first sub-component of putting on middle member, wherein, each container is connected to adjacent container removedly, and described package system all is contained in the first sealing member.Described method further comprises the steps: to remove described sealing member in gnotobasis; At least the second sub-component is connected to described the first sub-component and the second sealing member is attached to described sealing surfaces with the aseptic plate rail grid of the finished product of formation sealed container, and wherein each container holds the multi-part formula medical product of finished product.
To those of ordinary skills, by reading following detailed description and suitably with reference to accompanying drawing, these of each aspect of the present invention and other advantage will become obvious.
Scope of the present invention is determined by the content of claim.The invention is not restricted to specific embodiment, but comprise the combination in any of the element of different embodiment.And, the present invention includes any combination of claim and any combination of the disclosed feature of claim.
Description of drawings
Example embodiment is described with reference to accompanying drawing at this, in the accompanying drawings:
Fig. 1 illustrates the top view of a possible embodiment of plate rail system;
Fig. 2 illustrates the top view of another possible embodiment of the plate rail system that keeps two separate parts;
Fig. 3 illustrates the side cross-sectional view of the embodiment of a container from the plate rail system that holds finished product medicine carrying module;
Fig. 4 illustrates the single plate rail of the bottom with sealing, and this plate rail is positioned in two paper tinsel bags as sterile barrier;
Fig. 5 illustrates 10 plate rails stacking of the bottom with sealing, is separated and is positioned in the protection carrier box with second protection sleeve by protection sleeve;
Fig. 6 illustrates 10 plate rails stacking of the bottom with sealing, is separated and is positioned in two paper tinsel bags as sterile barrier by protection sleeve;
Fig. 7 to Figure 11 illustrates the side cross-sectional view of the various configurations of plate rail system when the filling of motion process and assigned line;
Figure 12 illustrates the operation in pin sub-component in principal cartridge parts (filling out the pin (pin) of medicine) the Disk frame system that will be filled with pharmaceutical formulation;
Figure 13 illustrates the parts that the plate rail with sealing of completing is partitioned into package dimension; With
Figure 14 shows the encapsulation of the parts of subregion.
The specific embodiment
The disclosure comprises a kind of encapsulation or plate rail system, its any type, that consisted of by two or more parts and must keep filling, assembling and the encapsulation of aseptic medical product or device in some assembling procedures in use.Below describe in detail for a kind of this class only possible be the multi-part formula medical product of medicine carrying module, described medicine carrying module is designed to use together with patient's main ingredient thing delivery apparatus with allowing the combined administration with two or more medicaments.More specifically, the medicine carrying module is used for using in company with the main ingredient compounds of variable dose or the first medical compounds via single output or medicine dispensing interface the inferior medical compounds (medicament) of fixing predetermined close.Plate rail of the present disclosure system can be configured to: in initially the sub-component of medicine carrying module being remained on the grid of the container that connects removedly, and motion is through aseptic filling and assigned line, on described line, then described sub-component is filled with medicament, described module is assembled, described container is sealed is divided into less array for encapsulation and is distributed to the end user.Use this system to make: in Fabrication procedure's process the medicine carrying module from single open the beginning grid remove and/or the sterile working step minimized.Yet, in some cases, may be in Fabrication procedure's process with medicine carrying module or its parts from plate rail remove and the plate rail of resetting back when specific manufacturing step is completed.
Fig. 1 illustrates the top view that opens beginning grid or plate rail system 1 of container 2, and it has 7 * 10 containers of rectangular shape.Certainly, the disclosure is not limited to any specific size or shape.The disclosure also can be not limited to the container 2 of specific quantity.Preferably, open the beginning size and dimension based on following and select, that is, based on will be for the concrete manufacturing equipment that the medicine carrying module that is contained in each container is filled and assembled, or be based upon the end user and encapsulate desired structure.Open beginning grid 1 and comprise level bearing 3.Level bearing 3 is allowed that individual container 2 is separated from one another and is removed.Open beginning grid 1 and also comprise eyelet 5, described eyelet 5 is allowed: the dispersion row that holds 7 containers can separate from grid 1, to be used for individual encapsulation and to be distributed to the end user.Fig. 2 illustrates another possible plate rail design, and this plate rail remains on two separate parts respectively in two distinct container 2a and 2b.These two parts finally connect together to form single medical components in assembling procedure.
Fig. 3 illustrates single container 2, this single container 2 hold be positioned at put on middle member 6 and by sealing member 7 sterilely seal fully the assembling medicine carrying module 9.For fear of part radially motion in the assembling procedure process of module 9, the form of having made in container 2 coordinates 6a, and this form coordinates 6a that described parts are remained in fixing radial position.Each container 2 has folded edge 4(and sees Fig. 1), described folded edge 4 allows that the user is from the top removal sealing member 7 of container.Initially, hold the container 2 of sub-component 8 only as shown in Fig. 4 the best.
Fig. 7 to Figure 11 is illustrated in an embodiment of the plate rail system 1 in each stage of Fabrication procedure.Fig. 7 illustrates grid 1, and it is wrapped in protection the first sealing member 10 and opens beginning plate rail system 1 aseptic to keep.The second sealing member 11 hides the open top of container 2 to keep the aseptic of parts or sub-component 8.Perhaps, as shown in Figure 4, this second sealing member 11 can be completed by the second bag of 11a that is completely enclosed within the first sealing member 10.This opens beginning plate rail system and 1 will receive from the builder of medicine carrying subassembly 8.The stacking of this class plate rail system 1 can be Fabrication procedure and prepares and sterilely provide in the box that is positioned at as shown in Figure 5, and wherein, plate rail 1 is stacking and be placed in box 50, and protection sleeve 52 is placed in when pollution risk is high between its each layer.Then this box 50 is sealed in bag 51.Perhaps, the second protective bag 53 that box 50 can be shown in Figure 6 replaces.
Refer again to Fig. 7, be mounted with sub-component 8 and preferably utilize subsequently gamma ray or epoxyethane (ethylene-oxide) to carry out disinfection with the grid 1 of the container 2 of the second sealing member 11 sealing.Put middle member 6 by utilization and keep each sub-components 8, plate rail system 1 can stand high speed/high-throughput, use robot to carry out to fill and the automation of final package program is filled and assembling is processed.The constituent material of grid 1 should have enough dynamic rates with the processing of the Fabrication procedure of bearing high speed/high-throughput.After Fig. 8 is illustrated in and enters the clean room, after outside seal may 10 has been removed and be right after plate rail system 1 before inferior sealing member 11 is removed along the direction of arrow 112.
When moving through the clean room, Fig. 9 illustrates a part of medicament 13 being added to the robot tucker 12 of each sub-component 8.Preferably, fill and carry out as single step, and each sub-component 8 is filled simultaneously.Put member 6 and guarantee accuracy and efficiency in filling work procedure.In some cases, medicament 13 may be enclosed in the medicine bottle of sealing or cartridge case 60 and only be placed in sub-component 8 as shown in figure 12.In case medicament 13 is added, the second medicine carrying subassembly 14 is fixed to the first sub-component 8 with regard to using robot assembling equipment (not shown), as shown in figure 10.Again, preferred the second sub-component 14 side by side is fixed to the first sub-component 8 in single step.The inner cavity chamber of each container 2 must have certain structure and/or size adapting to the connection of this second sub-component 14, described the second sub-component 14 sealings and finally complete each medicine carrying module 9.In some cases, filling/assembly mechanical 12 with may be for filling or the number of assembling steps align unit becomes necessary from the mutual effect of the medicine carrying module 9 of the bottom side of plate rail 1.In the case, plate rail 1 can have the open bottom that seals after a while in Fabrication procedure.So, can exist sealed bottom surperficial.Before leaving the clean room, interpolation the 3rd and final sealing member 7 are sterilely to seal each container 2, as shown in figure 11.Similarly, if need lower seals, it will be fixed to plate rail 1 before leaving the clean room.In case sealed, but grid 1 just across pitch line 3 or eyelet 5 cut or divide less grid into, for example the row of the piece of 14 containers 2 or 7 containers or any other can be then directly by commercial packages to be distributed to measuring easily for the user of user.This illustrates at Figure 13 and Figure 14, wherein, and from plate rail 1 subregion trip 57, then be encapsulated in box or case 58 (Figure 14).Before subregion or encapsulation, level bearing or eyelet can add final sealing member 7 to, so that it is easier to remove individual container 2 from final reduced size grid.
Perhaps, the inner cavity chamber of container 2 can have sealable open bottom.This may need, so as the part of allowing robot tucker 12 on automation filling and assigned line filling and the number of assembling steps process in and keep simultaneously and utilize applying nozzle when being positioned in container 2 or utilize the second sub-component 14 and support the alignment of the first sub-component 8.No matter be sealed in top or bottom or in both sides, label or out of Memory all can be applied directly to final sealing member material as required.
Example embodiment of the present invention has been done description.Yet, it will be understood by those skilled in the art that and can change and modification these embodiment in the situation that do not deviate from by the determined true scope of the present invention of claim and spirit.
Reference numeral
1 opens beginning grid/plate rail system
2 containers
The 2a container
The 2b container
3 level bearings
4 edges
5 eyelets
6 put middle member
The 6a form coordinates
7 sealing members
8 first sub-components
9 medicine carrying modules
10 first sealing members
11 second sealing members
Second bag of 11a
12 tuckers
13 medicaments
14 second sub-components
50 boxes
51 bags
52 protection sleeves
53 second protective bags
57 row
58 boxes
60 cartridge cases
112 arrows
Claims (17)
1. package system, be configured to use in the assembling procedure process, comprise: the aseptic plate rail grid (1) of the container of at least two connections (2), wherein, each container (2) has top seal surface and inner cavity chamber, what described inner cavity chamber had at least one sub-component (8) of being configured to support multi-part formula medical product puts middle member (6), and described at least one sub-component (8) is positioned at described putting on middle member (6), fixes thus described sub-component (8) and avoids motion.
2. package system as claimed in claim 1, wherein, a plurality of aseptic plate rail grids (1) are stacking each other.
3. as the described package system of any one of aforementioned claim,
Wherein, each container (2) is connected to adjacent container (2) via level bearing (3), and described level bearing (3) is configured to allow described container (2) is separated from one another and removes.
4. as the described package system of any one of aforementioned claim, wherein, each container (2) has the sealed bottom surface.
5. as the described package system of any one of aforementioned claim,
Wherein, described package system is for to use in the manufacturing process of described multi-part formula medical product, and described inner cavity chamber is configured to receive the part of automatic chemical drug thing filling machine temporarily.
6. as the described package system of any one of aforementioned claim,
Wherein, each container (2) is molded with plastics, and described plastics are configured to have enough rigidity, process and/or can utilize gamma ray or utilize epoxyethane to carry out asepticize for use in process automation medicine filling and assigned line.
7. as the described package system of any one of aforementioned claim, comprise described at least one sub-component (8), wherein, described sub-component (8) is supported by the described middle member (6) of putting, and the described middle member (6) of putting is configured to fixing described sub-component (8) in order to avoid rotatablely move.
8. as the described package system of any one of aforementioned claim, wherein, described grid (1) is wrapped in removable sealing member (10).
9. as the described package system of any one of aforementioned claim,
Wherein, described package system holds at least one another sub-component (14), and wherein said sub-component (8,14) is configured to form described multi-part formula medical product.
10. package system as claimed in claim 9,
Wherein, described multi-part formula medical product comprises medicine carrying module (9), and described medicine carrying module (9) is positioned at the described middle member (8) of putting and goes up and be in described inner cavity chamber.
11. as the described package system of any one of aforementioned claim,
Wherein, described top seal surface is adhered to another removable sealing member (11,11a, 7), with the aseptic of the contents of keeping each container (2).
12. package system as claimed in claim 11,
Wherein, each container (2) has and allows the folded edge (4) that described sealing member (11,11a, 7) is removed from described container (2).
13. package system as described in claim 11 or 12,
Wherein, described another removable sealing member (7) has the eyelet (5) that marks each container (2) profile.
14. package system as described in any one of claim 10 to 13,
Wherein, described medicine carrying module (9) comprises time medicament and medicine dispensing interface, and can be attached to the drug delivery device that holds major pharmaceutical.
15. as the described package system of any one of aforementioned claim,
Wherein, the aseptic plate rail grid (1) of described container (2) is configured to be partitioned into end user's grid used (57) and is placed in commercial packages (58).
16. a method of using aseptic plate rail grid (1) assembling multi-part formula medical product comprises the steps:
A., package system as described in any one of claim 1 to 16 is provided, wherein said package system all be contained in sealing member (10,11,11a) in;
B. remove in gnotobasis described sealing member (10,11,11a);
C. at least one second sub-component (14) is connected to corresponding the first sub-component (8), to form the multi-part formula medical product of corresponding finished product; With
D. another sealing member (7) is attached to described sealing surfaces, with the aseptic plate rail grid (1) of the sealed container (2) that forms finished product, wherein, corresponding container (2) holds corresponding multi-part formula medical product.
17. method as claimed in claim 16,
Wherein, at attached described another sealing member (7) before, medicament is added to described the first sub-component (8) under germ-free condition.
Applications Claiming Priority (5)
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| EP10186923 | 2010-10-08 | ||
| PCT/EP2011/064504 WO2012025549A1 (en) | 2010-08-27 | 2011-08-24 | Packaging system for multi-component medical products |
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| CN103180219B CN103180219B (en) | 2015-09-30 |
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| EP (1) | EP2609019B1 (en) |
| JP (1) | JP5847180B2 (en) |
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Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102012103896A1 (en) | 2012-05-03 | 2013-11-07 | Schott Ag | Supporting structure for simultaneously holding a plurality of medical or pharmaceutical containers and transport or packaging container with self |
| EP2848882B1 (en) | 2012-05-03 | 2016-03-09 | Schott AG | Method and device for crimping containers for the storage of substances for medical, pharmaceutical or cosmetic uses |
| DE102012111624A1 (en) | 2012-05-03 | 2013-11-07 | Schott Ag | Process for treating or processing containers for medical or pharmaceutical applications and carriers and transport or packaging containers therefor |
| DE102012103898A1 (en) | 2012-05-03 | 2013-11-07 | Schott Ag | Supporting structure for simultaneously holding a plurality of medical or pharmaceutical containers and transport or packaging container with self |
| DE102012110339B4 (en) | 2012-05-03 | 2014-04-10 | Schott Ag | Holding structure for simultaneously holding a plurality of medical or pharmaceutical containers as well as transport or packaging containers with self and method for treating such containers |
| DE102012103899B4 (en) | 2012-05-03 | 2016-09-22 | Schott Ag | Method and device for treating containers for storing substances for medical or pharmaceutical applications |
| EP2659981B1 (en) | 2012-05-03 | 2016-03-23 | Schott AG | Transport or packaging container with a support structure for simultaneously holding a plurality of containers for medical, pharmaceutical or cosmetic applications and method for treating such containers |
| CN106029121A (en) * | 2014-02-24 | 2016-10-12 | 诺和诺德股份有限公司 | Dose titration aid |
| US20160059980A1 (en) * | 2014-08-26 | 2016-03-03 | Howmedica Osteonics Corp. | Methods for packaging and shipping surgical instruments and implants |
| WO2016127031A1 (en) * | 2015-02-06 | 2016-08-11 | Regeneron Pharmaceuticals, Inc. | Aseptic drug delivery system and methods |
| CN109665202A (en) * | 2018-11-19 | 2019-04-23 | 亳州市天红消毒产品有限公司 | A kind of board-like disinfecting hemostasis combined complete easily taken |
| DE102021120303A1 (en) | 2021-08-04 | 2023-02-09 | Valeo Schalter Und Sensoren Gmbh | Storage device for storing several sensors with several individual storage elements |
| BE1030999B1 (en) * | 2022-10-27 | 2024-06-04 | Cenexi Laborathoires Thissen | Syringe filling process |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR1300356A (en) * | 1960-07-28 | 1962-08-03 | Gillette Industries Ltd | Packaging improvements for hypodermic needles |
| JPH06321268A (en) * | 1993-05-07 | 1994-11-22 | Matsutani Seisakusho Co Ltd | Container for medical instrument |
| EP0790063A1 (en) * | 1996-02-08 | 1997-08-20 | Becton, Dickinson and Company | A modular rack system for use in packaging and handling syringe barrels |
| WO2001076664A1 (en) * | 2000-04-07 | 2001-10-18 | Equidyne Systems, Inc. | Low cost disposable needleless injector system for variable and fixed dose applications |
| CN1749120A (en) * | 2005-09-08 | 2006-03-22 | 湖南千山制药机械股份有限公司 | Method for producing non-PVC multiple chamber large transfusion bag capable of avoiding water in solid medicine chamber after sterilizing |
| CN1817747A (en) * | 2006-03-03 | 2006-08-16 | 湖南千山制药机械股份有限公司 | Production of multiple chamber-bags for large infusion for preventing from opening pollution at charging after sterilization |
| WO2009153014A1 (en) * | 2008-06-19 | 2009-12-23 | Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg | Method for filling dual-chamber systems in pre-sterilizable carrier systems and pre-sterilizable carrier system |
Family Cites Families (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2503147A (en) * | 1944-12-21 | 1950-04-04 | Applezweig Norman | Carpule filling machine |
| US3643812A (en) * | 1970-06-12 | 1972-02-22 | Owens Illinois Inc | Tube storage rack |
| US4444310A (en) * | 1982-07-26 | 1984-04-24 | Becton, Dickinson And Company | Segmented multi-product package assembly |
| US4753345A (en) * | 1984-06-14 | 1988-06-28 | American Home Products Corporation | Hypodermic syringe tray |
| US4867315A (en) * | 1988-06-06 | 1989-09-19 | Baldwin Brian E | Vial filling, holding and serving tray arrangement and method |
| DE4303501A1 (en) * | 1993-02-06 | 1994-08-11 | Hans Schwartz | Holding device |
| JPH0999042A (en) * | 1995-10-02 | 1997-04-15 | Material Eng Tech Lab Inc | Sterilizing method for medicine |
| JP4790120B2 (en) * | 1998-03-13 | 2011-10-12 | ベクトン・ディキンソン・アンド・カンパニー | Manufacturing, filling and packaging methods for medical containers |
| US6286678B1 (en) * | 1999-03-05 | 2001-09-11 | Rainin Instruments Co., Inc. | Refill pack for pipette tip racks and improved pipette tip support plate for use in such packs and racks |
| US6305541B1 (en) * | 1999-09-15 | 2001-10-23 | John C. Tanner | Cartridge assembly packaging |
| FR2816924B1 (en) * | 2000-11-20 | 2003-02-14 | Becton Dickinson France | PACKAGING FOR STERILE PRODUCTS |
| FR2816925B1 (en) * | 2000-11-20 | 2003-02-14 | Becton Dickinson France | PACKAGING FOR PRODUCTS TO BE STERILIZED USING A HIGH TEMPERATURE STERILIZING FLUID |
| US6802828B2 (en) * | 2001-11-23 | 2004-10-12 | Duoject Medical Systems, Inc. | System for filling and assembling pharmaceutical delivery devices |
| US7169361B2 (en) * | 2002-01-10 | 2007-01-30 | Molecular Bioproducts, Inc. | Pipette tip reloading system |
| FR2838721B1 (en) * | 2002-04-22 | 2004-12-03 | Becton Dickinson France | PACKAGE FOR USE IN CONVEYING OR STERILIZING OBJECTS |
| US6883222B2 (en) * | 2002-10-16 | 2005-04-26 | Bioject Inc. | Drug cartridge assembly and method of manufacture |
| WO2004082745A1 (en) * | 2003-02-24 | 2004-09-30 | Becton Dickinson France | Plate for holding a group of syringe body objects |
| US7096896B2 (en) * | 2004-03-05 | 2006-08-29 | Medical Instill Technologies, Inc. | Apparatus and method for needle filling and laser resealing |
| US7232038B2 (en) * | 2004-04-27 | 2007-06-19 | Whitney Steven G | Disposable test tube rack |
| US7963396B2 (en) * | 2004-07-01 | 2011-06-21 | West Pharmaceutical Services, Inc. | Vacuum package system |
| US8100263B2 (en) * | 2004-07-01 | 2012-01-24 | West Pharmaceutical Services, Inc. | Vacuum package system |
| AU2005312310A1 (en) * | 2004-12-03 | 2006-06-08 | Duoject Medical Systems Inc. | Cartridge, device and method for pharmaceutical storage, mixing and delivery |
| US20060213793A1 (en) * | 2005-03-08 | 2006-09-28 | Christopher Brand | Syringe needle protector |
| EP2018332B1 (en) * | 2006-05-18 | 2017-04-12 | Maej, Llc | Delivery device with separate chambers connectable in fluid communication when ready for use, and related method |
| JP5412275B2 (en) * | 2007-03-05 | 2014-02-12 | 株式会社大協精工 | Medical container |
| EP2155303A1 (en) * | 2007-06-14 | 2010-02-24 | Sanofi-Aventis Deutschland GmbH | Dual-chamber carpule |
| EP2240155B1 (en) * | 2008-02-13 | 2012-06-06 | Intarcia Therapeutics, Inc | Devices, formulations, and methods for delivery of multiple beneficial agents |
| US8286791B2 (en) * | 2010-09-30 | 2012-10-16 | Tyco Healthcare Group Lp | Syringe assembly carrier |
| US8196741B2 (en) * | 2010-09-30 | 2012-06-12 | Tyco Healthcare Group Lp | Syringe assembly and package for distribution of same |
| JP4685198B1 (en) * | 2010-11-11 | 2011-05-18 | 株式会社アルテ | Manufacturing method of packaging plate, syringe holding container, and container combined syringe |
| JP5081330B1 (en) * | 2012-06-20 | 2012-11-28 | 株式会社アルテ | Syringe manufacturing cartridge set and two-chamber container-use syringe manufacturing method |
-
2011
- 2011-08-24 CA CA2809326A patent/CA2809326A1/en not_active Abandoned
- 2011-08-24 AU AU2011295037A patent/AU2011295037B2/en not_active Ceased
- 2011-08-24 CN CN201180051847.7A patent/CN103180219B/en not_active Expired - Fee Related
- 2011-08-24 DK DK11748931.0T patent/DK2609019T3/en active
- 2011-08-24 BR BR112013004774A patent/BR112013004774A2/en not_active IP Right Cessation
- 2011-08-24 JP JP2013525296A patent/JP5847180B2/en not_active Expired - Fee Related
- 2011-08-24 US US13/818,839 patent/US9365306B2/en not_active Expired - Fee Related
- 2011-08-24 WO PCT/EP2011/064504 patent/WO2012025549A1/en active Application Filing
- 2011-08-24 EP EP11748931.0A patent/EP2609019B1/en not_active Not-in-force
-
2013
- 2013-02-26 IL IL224938A patent/IL224938B/en not_active IP Right Cessation
- 2013-12-13 HK HK13113907.0A patent/HK1186442A1/en not_active IP Right Cessation
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR1300356A (en) * | 1960-07-28 | 1962-08-03 | Gillette Industries Ltd | Packaging improvements for hypodermic needles |
| JPH06321268A (en) * | 1993-05-07 | 1994-11-22 | Matsutani Seisakusho Co Ltd | Container for medical instrument |
| EP0790063A1 (en) * | 1996-02-08 | 1997-08-20 | Becton, Dickinson and Company | A modular rack system for use in packaging and handling syringe barrels |
| WO2001076664A1 (en) * | 2000-04-07 | 2001-10-18 | Equidyne Systems, Inc. | Low cost disposable needleless injector system for variable and fixed dose applications |
| CN1749120A (en) * | 2005-09-08 | 2006-03-22 | 湖南千山制药机械股份有限公司 | Method for producing non-PVC multiple chamber large transfusion bag capable of avoiding water in solid medicine chamber after sterilizing |
| CN1817747A (en) * | 2006-03-03 | 2006-08-16 | 湖南千山制药机械股份有限公司 | Production of multiple chamber-bags for large infusion for preventing from opening pollution at charging after sterilization |
| WO2009153014A1 (en) * | 2008-06-19 | 2009-12-23 | Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg | Method for filling dual-chamber systems in pre-sterilizable carrier systems and pre-sterilizable carrier system |
Also Published As
| Publication number | Publication date |
|---|---|
| US9365306B2 (en) | 2016-06-14 |
| CA2809326A1 (en) | 2012-03-01 |
| AU2011295037A1 (en) | 2013-03-14 |
| JP2013539385A (en) | 2013-10-24 |
| HK1186442A1 (en) | 2014-03-14 |
| JP5847180B2 (en) | 2016-01-20 |
| EP2609019B1 (en) | 2015-02-18 |
| IL224938B (en) | 2018-03-29 |
| EP2609019A1 (en) | 2013-07-03 |
| US20130152510A1 (en) | 2013-06-20 |
| AU2011295037B2 (en) | 2015-05-14 |
| DK2609019T3 (en) | 2015-05-26 |
| WO2012025549A1 (en) | 2012-03-01 |
| CN103180219B (en) | 2015-09-30 |
| BR112013004774A2 (en) | 2016-08-09 |
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